Childhood ObesityINFOBNCT03764579
Dietary Habits and Sleep in Childhood Obesity
A study testing sleep and diet intervention vs diet intervention in people with Childhood Obesity and Life Style, run by University of Valencia at 1 site in Spain.
Trial summary
Recruitment of obese children, classification according to sleep questionnaire and randomization in two groups to perform nutritional and sleep intervention. . One group receives dietary intervention through recommendations. A group receives dietary and sleep intervention through recommendations. Read more about this study
- Who is it for?
- Ages 7 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity, Life Style, Circadian Rhythms
- What is being tested?
- sleep and diet intervention vs diet intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 29 Nov 2018to 29 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children between 7 and 14 years old
- overweight or obese (Body Mass Index superior to 97th percentile for age and sex).
Who cannot join
- Medicine intake,
- hyperactivity,
- infectious inflammatory processes,
- elite athletes.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Pilar Codoñer Franch
Valencia, 46010
PILAR CODOÑER, +34 670320624, pilar.codoner@uv.es
About this study
Official title: Sleep and Nutrition Intervention in Obese Children, Effects on Circadian Rhythms, Metabolic and Inflammatory Status
Recruitment of obese children, classification according to sleep questionnaire and randomization in two groups to perform nutritional and sleep intervention. .
One group receives dietary intervention through recommendations. A group receives dietary and sleep intervention through recommendations. An analysis of the melatonin profile and metabolic and inflammatory status is performed by biochemistry at the beginning and end of the intervention. Determine if the intervention has improved the health of obese children.
Read the detailed description
This study is carried out in children aged 7 to 14 years who are overweight or obese, in which their state and circadian rhythm variation are related by means of melatonin, biochemistry and dietary and sleep questionnaires.
An intervention is performed in which patients are classified in evening and morning. After the classification, a randomized randomization is carried out in which one group receives dietary recommendations and another group receives dietary and sleep recommendations. After 6 months of follow-up the analyzes are performed again to observe possible differences with the initial values and compare it between both groups.
- Conditions
- Childhood Obesity, Life Style, Circadian Rhythms
- Being tested
- sleep and diet intervention vs diet intervention
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sleep and diet intervention vs diet interventionBehavioural
lifestyle healthy food and use Harvard plate and reduce use electronic device prior sleep.
| Study group | Role | What they receive |
|---|---|---|
| sleep and diet intervention | Active comparator | Not described Receives: Behavioral: sleep and diet intervention vs diet intervention |
| diet intervention | Active comparator | Not described Receives: Behavioral: sleep and diet intervention vs diet intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index measurement, percentile for age and sex
comparative measurements prior after intervention
Measured: 6 months
Secondary outcomes (1)
melatonin concentration profile in saliva
comparative measurements prior after intervention
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start29 Nov 2018
- Primary completion29 Nov 2019 (estimated)
- Study completion29 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pilar Codoñer-Franch, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03764579
- Sponsor's protocol ID
- University of Valencia-POG
- Acronym
- INFOB
- Status last verified
- Dec 2018
- First submitted
- 30 Nov 2018
- Last updated
- 5 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep and Nutrition Intervention in Obese Children, Effects on Circadian Rhythms, Metabolic and Inflammatory Status
- ClinicalTrials.gov ID
- NCT03764579
- Acronym / sponsor ID
- INFOB / University of Valencia-POG
- Conditions
- Childhood Obesity, Life Style, Circadian Rhythms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 29 Nov 2018 (actual)
- Primary completion
- 29 Nov 2019 (estimated)
- Study completion
- 29 Nov 2020 (estimated)
- First posted
- 5 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recruitment of obese children, classification according to sleep questionnaire and randomization in two groups to perform nutritional and sleep intervention. .
One group receives dietary intervention through recommendations. A group receives dietary and sleep intervention through recommendations. An analysis of the melatonin profile and metabolic and inflammatory status is performed by biochemistry at the beginning and end of the intervention. Determine if the intervention has improved the health of obese children.
Detailed description
This study is carried out in children aged 7 to 14 years who are overweight or obese, in which their state and circadian rhythm variation are related by means of melatonin, biochemistry and dietary and sleep questionnaires.
An intervention is performed in which patients are classified in evening and morning. After the classification, a randomized randomization is carried out in which one group receives dietary recommendations and another group receives dietary and sleep recommendations. After 6 months of follow-up the analyzes are performed again to observe possible differences with the initial values and compare it between both groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sleep and diet intervention | Active comparator | Behavioral: sleep and diet intervention vs diet intervention |
| diet intervention | Active comparator | Behavioral: sleep and diet intervention vs diet intervention |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- children between 7 and 14 years old
- overweight or obese (Body Mass Index superior to 97th percentile for age and sex).
Key exclusion criteria (4 listed)
- Medicine intake,
- hyperactivity,
- infectious inflammatory processes,
- elite athletes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sleep and diet intervention vs diet interventionlifestyle healthy food and use Harvard plate and reduce use electronic device prior sleep. | Behavioural | diet intervention, sleep and diet intervention |
Primary outcome
Body mass index measurement, percentile for age and sex
Time frame: 6 months
comparative measurements prior after intervention
1 secondary outcome
melatonin concentration profile in saliva
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sleep and diet intervention vs diet intervention in people with Childhood Obesity and Life Style, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body mass index measurement, percentile for age and sex (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2018.